Application 078306

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL100MGNoNo
002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL200MGNoNo
003VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6201Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6201Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6201Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6202Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6202Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6202Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6203Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6203Verapamil Hydrochlorideverapamil hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9141ORIG2007-08-14